Sanofi's combination diabetes drug hits goal in second late-stage trial

[September 14, 2015]  PARIS (Reuters) - Sanofi said on Monday a second late-stage Phase III study of its LixiLan diabetes drug had met its main target, readying it for regulatory submissions by the fourth quarter in the United States and the first quarter of next year in the European Union.

LixiLan consists of a single-injection combination of Lyxumia, a drug developed with Danish drugmaker Zealand Pharma, and Sanofi's Lantus. It targets patients suffering from type 2 diabetes.

"Full results will be communicated in a future scientific forum," the French drugmaker said in a statement.

"The LixiLan-L Phase III clinical trial met its primary endpoint in patients with type 2 diabetes treated with insulin glargine with or without metformin. The fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide, a GLP-1 receptor agonist, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with insulin glargine 100 Units/mL," it said.

In July, Sanofi said a first late-stage Phase III study of LixiLan had shown satisfactory results.

Nearly 400 million people worldwide have diabetes, with type 2 accounting for more than 90 percent of cases. Without proper treatment or lifestyle changes, those numbers are expected to grow substantially in the coming years.

(Reporting by Matthias Blamont; Editing by Elaine Hardcastle)

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